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Contents
Title and Copyright Information
Preface
Where to Find More Information
Documentation Accessibility
Part I Prepare to Install Argus Safety
1
System Requirements
1.1
Hardware Requirements for Argus Safety
1.2
Software Requirements for Argus Safety
1.2.1
Operating System
1.2.2
Oracle Components
1.2.3
Other Components
1.2.4
Generic—Other Supported Features
2
Install Oracle Database
2.1
Get the Oracle Database Installation Guide
2.2
Download and Extract the Oracle Database Software
2.3
Install Oracle Database
2.3.1
Database Software Installation Options
2.3.2
Database Configuration Options
2.3.3
Install and Apply Oracle Patch Set
2.4
Set Up Database Parameters
2.4.1
Argus Safety Database Instance Parameters (Recommended)
2.4.2
Additional Database Setup Information
2.5
Table Partitioning (Optional)
Part II Set Up Argus Safety Middle and Client Tiers
3
Install and Configure Argus Safety Web
3.1
Prerequisites
3.2
Install Argus Safety Web
3.3
Enable SSL Support for Windows Server
3.4
Configure Load Balancer in Argus Web
3.4.1
Set Up Argus Web Load Balancer IP Address
3.4.2
Set Up Shared Network Directory
3.5
Reset IIS
4
Enable IIS HTTP Compression
4.1
IIS Web Page Compression
4.1.1
HTTP Compression
4.1.2
Known Effects of Enabling Compression
4.1.3
Enable HTTP Compression
4.2
IIS Caching Settings
4.2.1
IIS Caching
4.2.2
Known Effects of Enabling Caching
4.2.3
Enable Caching
4.3
Local Internet Explorer (IE) Client Caching Settings
4.3.1
IE Client Caching
4.3.2
Enable IE Caching
4.3.3
IE Client Caching—Tab Options
5
Install and Start Argus Safety Service
5.1
Install Argus Safety Service
5.2
Start Argus Safety Service
5.3
Set Up RightFax
6
Install and Configure Interchange
6.1
Prerequisites
6.2
Install Interchange Service
6.3
Configure Interchange Service
6.4
Access EDI Gateway Shared Folders
6.5
Configure Interchange Service .INI File
7
Set Up the Client Browser
7.1
Prerequisites
7.2
Install Files Required to View Japanese Text (For Japanese installation only)
7.3
Configure Internet Explorer
7.4
Add the Argus Site as a Local Intranet Site
7.5
Add Argus Site to the Enterprise Mode
7.6
Set Up Compatibility View with Internet Explorer
8
Post-installation Checks
8.1
Post-Installation Tasks
8.1.1
General Checklist
8.1.2
Configure Worklist Intake
8.1.2.1
RelsysWindowsService.exe.config
8.1.2.2
Service.config
8.1.2.3
Intake.config
8.1.3
Verify and Update Network Proxy Settings
8.2
Verify Files Installed on Middle Tier Servers
9
Other Tasks
9.1
Configure Argus.xml File
9.2
Configure Argus.ini File
9.2.1
Argus.ini Parameters
9.3
Install SSO on Oracle Access Manager 11g
9.3.1
Prerequisites
9.3.2
Install SSO
9.4
Installation Maintenance Tasks
9.4.1
Install New Components
9.4.2
Uninstall Components
9.4.3
Remove All Components
9.5
Argus Configuration Files
9.5.1
Backup Configuration Files
Part III Install or Upgrade Argus Safety Database Tier
10
Install Argus Safety Database
10.1
Create Argus Safety Database Schema
10.1.1
Prepare to execute the DBInstaller
10.1.1.1
Prerequisites
10.1.1.2
Install Java
10.1.1.3
Set Java Install Path
10.1.1.4
Install XDB Schema for Interchange
10.1.2
Run Create DBA User Script
10.1.3
Create Tablespaces (Optional)
10.1.4
Prerequisites to Create the Schema
10.1.5
Configure the Database Setup Properties File
10.1.6
Create the Schema on Windows from the User Interface
10.1.7
Create the Schema on Windows from a Batch file
10.1.8
Create the Schema on Linux or Unix
10.2
Post Fresh Install Steps
10.3
Oracle Text
10.4
Validate Argus Safety Database
10.4.1
Validate Argus Safety Database on Windows
10.4.2
Validate Argus Safety Database on Linux or Unix
10.5
Enable and Disable Data Lock Point (DLP)
10.5.1
Prerequisites
10.5.2
Enable DLP
10.5.3
Disable DLP
10.6
Enable DLP on a Specific Enterprise
10.6.1
Set Up the Base Database
10.6.2
Enable DLP on Specific Enterprise or Delta Cases
10.6.3
Validate the Schema
10.7
Copy Configuration Data (Optional)
10.7.1
Set Up the Copy Configuration Tool
10.7.2
Use the Copy Configuration Tool
10.8
Create Argus Safety Read-only Database Account (Optional)
11
Upgrade Argus Safety Database
11.1
Prerequisites for Database Upgrade
11.2
Argus Safety Database Upgrade
11.3
Post Upgrade Steps
11.4
Enable Local Locking in Argus Safety
11.5
Merge a Single Enterprise Safety Database into a Multi-tenant Database
11.5.1
Prerequisites to Run the Merge Export Step
11.5.2
Merge Export
11.5.3
Export the dmp File Copy to the Target Database Server
11.5.4
Prerequisites to Run the Merge Import Step
11.5.5
Merge Import
11.5.6
Synchronize Dictionary Manually
Part IV Configure Other Products
12
Configure and Enable Argus Dossier
12.1
Prerequisites
12.2
Configure Dossier
12.3
Enable Dossier
13
Install and Configure Axway B2Bi
13.1
Create an Axway B2Bi Database Instance
13.2
Install Axway B2Bi
13.3
Configure Axway B2Bi
13.3.1
Configure Axway B2Bi for Binary File Transmission
13.3.2
Configure Axway B2Bi Community
13.3.2.1
Register with the Axway B2Bi Community
13.3.2.2
Add a Partner to the Axway B2Bi Community
13.3.2.3
Register the Receiver's Community on the Sender Server
13.3.3
Add a Node
13.3.4
Configure Axway B2Bi Certificates
13.3.4.1
Configure Receiver Axway B2Bi Certificates
13.3.4.2
Configure Sender Axway B2Bi Certificates
13.3.5
Configuring EVENTS.XML
13.3.6
Configure Message Processing Settings
13.4
Test Communication
14
Install and Configure Oracle B2B
14.1
Install Oracle B2B
14.2
Integrate Oracle B2B with Argus Safety
14.3
Create Integration tables in B2B Schema
14.4
Configure Oracle B2B User Interface
14.4.1
General Configuration > Administration > Configuration
14.4.2
Document Configuration > Administration > Document
14.5
Configure Enterprise Manager
14.5.1
Deploy SOA Composite
14.5.2
Configure SOA Composite
14.5.2.1
AS_BPEL_Outbound Composite
14.5.2.2
AS_BPEL_Inbound Composite
14.6
Configure Web Logic Console
14.6.1
Data source with JNDI Name as 'eis/DB/ArgusSafety_Outbound'
14.6.2
Data source as 'jdbc/ArgusSafety_Inbound'
14.6.3
Data source with JNDI Name as 'eis/DB/ArgusSafety_Inbound'
14.6.4
DB Adapters for Data Source
14.7
Configure Large Payload Exchange
14.7.1
Outbound Files
14.7.2
Inbound Files
14.7.3
Transaction Time
14.7.4
General B2B Settings for Large Payloads
14.8
Configurations for Argus Safety
14.8.1
Configure Oracle B2B
14.8.2
Update for B2B Documents
14.8.3
Argus Console > Reporting Destination Code List
15
Configure OBIEE or BI Publisher
15.1
Prepare BI Publisher Server
15.2
Set Up BI Publisher for Argus Safety
15.2.1
Enable a Local Superuser
15.2.2
Create a Database Connection
15.2.3
Set Up Runtime BI Publisher Memory
15.2.4
Configure Oracle Fusion Middleware Security Model
15.3
Manage Users and Roles
15.3.1
Configure Users, Groups and Roles
15.3.1.1
Create a Group
15.3.1.2
Create a User
15.3.1.3
Create an Application Role
15.3.2
Create Application Policies and Set Up Folder Privileges (BI Publisher Standalone only)
15.3.2.1
Create Application Policies
15.3.2.2
Manage Folder Privileges
15.3.3
Create Application Policies and Set Up Folder Privileges (OBIEE and BI Integrated Installation only)
15.3.3.1
Create Application Policies
15.3.3.2
Manage Folder Privileges
15.4
Upload BI Publisher Reports
15.4.1
Flexible Aggregate Reports
15.4.2
PMDA R3 Paper Reports
15.5
Integrate Argus Safety with BI Publisher
15.5.1
Configure AG Service
15.5.2
Configure Web Service (Expedited Reports only)
15.5.3
Add AG Service user to BI Publisher (Expedited Reports only)
15.5.4
Update SSO Exclusion List
15.6
Argus Console—BIP Common Settings
15.6.1
Configure BIP Reporting Admin User
15.6.2
Enable BIP Aggregate Reports and Configure Persistence Data (Flexible Aggregate Reporting only)
15.6.3
Configure Code Lists
15.6.3.1
Flexible Aggregate Reporting Code Lists
15.6.3.2
PMDA R3 Paper Forms Code lists
15.7
Configure Flexible Aggregate Reporting Database
15.7.1
Execute Argus_BIP_Enable
15.7.2
Database Jobs
15.7.2.1
Report Output Pusher
15.7.2.2
Persist Data Cleaner
15.8
Upgrade BIP Reports to 8.2.1
16
Install Argus Unblinding
16.1
Prerequisites
16.2
Install Argus Unblinding Utility
17
Configure Web Service Interfaces on Web Server
17.1
Prerequisites
17.2
Argus Web Service Interface
17.2.1
Argus Web Service Interface Framework
17.3
Edit .config Files
17.3.1
Edit the .config file for Outbound Interfaces
17.3.2
Edit the .config file for Inbound Interface
17.4
Safety Message
17.5
MedDRA Interface
17.5.1
MedDRA Configuration
17.5.1.1
Enable MedDRA Integration through Argus Console
17.5.1.2
Edit the ArgusWeb/ASP/web.config file
17.5.1.3
Edit the Argus.NET/web.config file
17.5.2
MedDRA Encoding Flow
17.5.3
Examples of MedDRA Encoding Safety Message
17.5.3.1
Request (V 2.0)
17.5.3.2
Response (V2.0)
17.5.3.3
Request (V 1.1)
17.5.3.4
Response (V 1.1)
17.5.3.5
Request (V 1.0)
17.5.3.6
Response (V 1.0)
17.5.4
MedDRA Interface XML Schema
17.5.4.1
MEDDRA_Request
17.5.4.2
MEDDRA_Response
17.6
Product Study License Interface
17.7
WHO Drug Coding Interface
17.7.1
Configuration
17.7.2
Drug Dictionary Coding Flow
17.7.3
Example of WHO Drug Coding Safety Message
17.7.3.1
Request
17.7.3.2
Response
17.7.4
WHO Drug Coding: XML Schema
17.7.4.1
Request: WHODrug_Request
17.7.4.2
Response: WHODrug_Response
17.8
Lot Number Interface
17.8.1
Configuration
17.8.2
Lot Validation Flow
17.8.3
Example of Lot Number Safety Message
17.8.3.1
Request
17.8.3.2
Response
17.8.4
Lot Number: XML Schema
17.8.4.1
Request: Lot_Request
17.8.4.2
Response: Lot_Response
17.8.5
Transformation
17.9
Worklist Intake
17.9.1
Configuration
17.9.2
Worklist Intake Flow
17.9.3
Example of Worklist Intake Safety Message
17.10
Literature Intake
17.10.1
Configuration
17.10.1.1
Metadata Configuration
17.10.2
Literature Intake Flow
17.11
Extended E2B Interface
18
Configure Argus Centralized Coding
18.1
setup_centralized_coding_interface_schema.bat
18.2
dms_migration.bat
18.2.1
Single Enterprise Migration in One Execution
18.2.2
All Enterprise Migration in One Execution
Part V Secure Argus Safety
19
Argus Password Management—Cryptography Tool
19.1
Install or Upgrade to Argus Safety 8.2.1
19.1.1
Generate New Cryptography Key
19.1.2
Argus Safety Database
19.1.3
Argus Safety Application Servers
19.2
Reset Password or Change the Cryptography Key
19.2.1
Reset the ARGUSUSER Password
19.2.2
Edit Keys
19.2.3
Re-encrypt Common User Passwords
19.2.4
Generate Encrypted String
19.2.5
Reset Administrator and System Application User Password
19.2.6
Reset the Environment if ArgusSecureKey.ini is Lost
A
Configure BI Publisher Security Model
A.1
Create Custom Roles and Assign Data Sources
A.2
Create Users and Assign Roles
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